Medical device and electronics assembly services
Operating two Class 100,000 cleanrooms totaling 1700 sq ft, Coastline International focuses on medical part and electronics assembly operations. The ISO 13485– and ISO 9001–certified company also plans to double its Class 100,000 cleanroom capacity this spring. Equipped with SMT and through-hole wave-soldering equipment, the company’s facility provides RoHS-compliant and surface-mount manufacturing services, in addition to such full-contract manufacturing services as parts procurement.
Coastline International Inc.
MackMedical/Mack Molding has added Class 100,000 cleanroom molding to its portfolio of medical device manufacturing services. Dedicated to the production of reusable and disposable medical devices for orthopedic applications in particular, the company’s modular cleanroom injection molding facility features removable panels to accommodate future expansion. Dual-air-lock, rapid-roll-up doors facilitate product flow and quick tool changes. The facility houses six high-precision, energy-efficient 110-tn electric injection molding machines. The service provider is equipped with 121 injection molding machines in total, ranging from 28 to 4000 tn in clamping force and from 0.6 to 800 oz in barrel size. It also has a Class 100,000 cleanroom dedicated to sonic-welding assembly, functional testing, and nonsterile packaging of disposables.
Contract manufacturing and assembly
Full-service, FDA-registered, and ISO 13485–certified contract manufacturer Sanbor Medical offers production and assembly of Class I and Class II medical devices. Services include full-system box build and the manufacture of handheld devices and single-use disposables. In addition, the company conducts assembly and packaging operations in a Class 10,000 cleanroom and provides sterilization services through its FDA-registered partners. It produces electromechanical subassemblies and plastic molded components, as well as finished devices. The service provider is equipped for high-volume production but has no minimum-volume requirement.
A full-service medical device contract manufacturer registered with FDA and operating a facility certified to ISO 13485:2003 standards, Life Science Outsourcing Inc. has 10,000 sq ft of Class 10,000 cleanroom space used primarily for the manufacture of Class II and Class III devices. The company can lease cleanroom space to OEMs on a daily, weekly, or monthly basis, providing allocated spaces for confidential or special projects. The cleanroom houses equipment, tooling, and assembly fixtures for ultrasonic component cleaning, ultrasonic welding, tray sealing, and such microprocesses as soldering. Providing a turnkey outsourcing solution for both startups and large medical device companies, the company offers sterilization, packaging validation, and warehousing services as well.
Life Science Outsourcing Inc.
Production, assembly, and testing services
Outsourcing partner MedPlast is a full-service custom medical device manufacturer equipped with Class 100,000 cleanrooms for molding and assembly. It also offers extensive product testing capabilities. Its in-house laboratory services include monitoring of the production environment for microbial contaminants that could compromise the final sterilized product. The company also performs bioburden and Limulus amebocyte lysate testing. In addition to lab tests, it conducts a variety of in-process and final testing during the manufacturing process, including customized pull testing, drop testing, leakage testing, flow testing, and electrical testing. The ISO 13485– and ISO 9002–certified and FDA-registered contract manufacturer offers capabilities in injection molding, blow molding, silicone materials, and silicone processing.
Published in MPMN, January/February 2013, Volume 29, No. 1
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